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Bipolar Plasmakinetic TURP Vs Monopolar TURP in the Treatment of Lower Urinary Tract Symptoms

  • Clinicaltrials.gov identifier

    NCT03936244

  • Recruitment Status

    Completed

  • First Posted

    May 3, 2019

  • Result First Posted

    October 19, 2020

  • Last update posted

    November 12, 2020

Study Description

Brief summary:

Randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution

  • Condition or Disease:Transurethral Resection of Prostate
    Prostatic Hyperplasia
    Lower Urinary Tract Symptoms
  • Intervention/Treatment: Device: Transurethral Resection of the Prostate (TURP)
  • Phase: N/A

Detailed Description

The study is a randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes (efficacy, complications and sequelae) for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution (Madrid, Spain)

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 100 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Official Title: Randomized Controlled Trial Comparing Bipolar Plasmakinetic Transurethral Resection of the Prostate With Monopolar Transurethral Resection of the Prostate in the Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
  • Actual Study Start Date: December 2014
  • Actual Primary Completion Date: December 2017
  • Actual Study Completion Date: December 2019

Arms and interventions

Arm Intervention/treatment
Active Comparator: M-TURP
The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator
Device: Transurethral Resection of the Prostate (TURP)
Randomized allocation to M-TURP or PK-TURP
Experimental: PK-TURP
The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator
Device: Transurethral Resection of the Prostate (TURP)
Randomized allocation to M-TURP or PK-TURP

Outcome Measures

  • Primary Outcome Measures: 1. International Prostate Symptom Score (IPSS) [ Time Frame: 12 months ]
    International Prostate Symptom Score (with 7 questions) at 1, 3, 6, and 12 months after surgery. Results: the sum of the 7 items will range between 0 to 35 points Interpretation: allows categorizing the lower urinary tract symptoms (LUTS) in 3 categories Mild LUTS: 0-7 points Moderate LUTS: 8-19 points Severe LUTS: 20-35 points
  • 2. Maximum Urinary Flow Rate (Qmax [ Time Frame: 12 months ]
    Maximum urinary flow rate (mL/s) at 1, 3, 6, and 12 months after surgery.
  • 3. Postvoid Residual Urine (PVRU) Volume [ Time Frame: 12 months ]
    Postvoid residual urine volume (mL) was measured by abdominal ultrasound after urination at 1, 3, 6, and 12 months after surgery.
  • Secondary Outcome Measures: 1. Stenotic Complications Rate: Bladder Neck Contracture [ Time Frame: 12 months ]
    Register the number of bladder neck contracture at 1, 3, 6, and 12 after surgery.
  • 2. Stress Urinary Incontinence Rate [ Time Frame: 12 months ]
    Register the number of patients with stress urinary incontinence at 1, 3, 6, and 12 after surgery.
  • 3. Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire [ Time Frame: 12 months ]
    We use the bother score item of the IPSS questionnaire (question 8) at 1, 3, 6, and 12 months after surgery to assess the quality of life (QoL) due to lower urinary tract symptoms (LUTS) Results: will range between 0 to 6 points Interpretation: allows categorizing the QoL in 3 categories Good QoL: 0-2 points Intermediate QoL: 3 points Poor QoL: 4-6points
  • 4. Number of Participants Reporting Sexual Activity in the Last Month [ Time Frame: 12 months ]
    Measure Description: All patients were asked, Did you have sexual activity in the last month? Possible answers were yes or no. Possible answers: yes or no. Measurement moment: at 1, 3, 6 and 12 months after surgery.
  • 5. International Index of Erectile Function (IIEF-5) [ Time Frame: 12 months ]
    International Index of Erectile Function (with 5 questions) at 1, 3, 6, and 12 months after surgery. Results: the sum of the 5 items will range between 1 to 25 points Interpretation: allows categorizing the erectile function of patients Without erectile dysfunction: 22-25 points Mild erectile dysfunction: 17-21 points Mild to moderate erectile dysfunction: 12-16 points Moderate erectile dysfunction: 8-11 points Severe erectile dysfunction: 1-7 points
  • 6. Prostate Volume (PV) [ Time Frame: 12 months ]
    Prostate volume was measured by transrectal ultrasound at 12 months after surgery
  • 7. Operative Time [ Time Frame: Up to 24 hours ]
    Operative time (min)
  • 8. Irrigation Volume [ Time Frame: Up to 24 hours ]
    Irrigation volume (L)
  • 9. Change in Plasmatic Sodium in 24 Hours Post-operation [ Time Frame: 24 hours after surgery ]
    Compared with the baseline, to demonstrate the sodium loss during operation
  • 10. Change in Haemoglobin in 24 Hours Post-operation [ Time Frame: 24 hours after surgery ]
    Compared with the baseline, to demonstrate the blood loss during operation
  • 11. Transfusion Rate [ Time Frame: 1 month ]
    Number of participants requiring blood transfusion during, expressed in %
  • 12. Catheter Duration [ Time Frame: 1 month ]
    Catheter duration (days)
  • 13. Hospital Stay [ Time Frame: 1 month ]
    Hospital stay (days)
  • 14. Resected Tissue Weigh [ Time Frame: Up to 24 hours ]
    Resected tissue weigh (grams)
  • 15. Resected Tissue Percentage [ Time Frame: Up to 24 hours ]
    Compared with the baseline, to demonstrate the % of tissue loss during operation
  • 16. Speed Resection [ Time Frame: Up to 24 hours ]
    Speed resection (g/min)
  • 17. Early Reoperation Rate [ Time Frame: 1 month ]
    The ratio of patient who need reoperation because bleeding complications
  • 18. Late Reoperation Rate [ Time Frame: 12 months ]
    The ratio of patient who need reoperation because residual adenoma or complications
  • 19. Post-TURP Syndrome Rate [ Time Frame: Up to 24 hours ]
    Post-transurethral resection of the prostate syndrome rate was recorded.
  • 20. Clavien Dindo System [ Time Frame: 12 months ]
    It is a system for evaluating surgical complications at 12 months after surgery. Clavien I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Acceptable therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, diuretics and electrolytes, and physiotherapy. Clavien II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included Clavien III - Requiring surgical, endoscopic or radiological intervention Clavien IV - Life-threatening complication (including central nervous system complications) requiring intensive care unit management Clavien V - Death of a patient
  • 21. Bleeding Complications Rate [ Time Frame: 1 month ]
    Register the number of events of haematuria and acute urinary retention by clots
  • 22. Urinary Tract Infections Rate [ Time Frame: 12 months ]
    Register the number of urinary tract infections at 1, 3, 6, and 12 months after surgery.
  • 23. Stenotic Complications Rate: Meatal Stenosis [ Time Frame: 12 months ]
    Register the number of meatal stenosis at 1, 3, 6, and 12 after surgery.
  • 24. Stenotic Complications Rate: Urethral Stricture [ Time Frame: 12 months ]
    Register the number of urethral stricture at 1, 3, 6, and 12 after surgery.
  • 25. Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate [ Time Frame: 12 months ]
    Register the number of patients with urge urinary incontinence with need for drug use at 1, 3, 6, and 12 after surgery.
  • 26. Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate [ Time Frame: 12 months ]
    Register the number of patients with urge urinary incontinence without need for drug use at 1, 3, 6, and 12 after surgery.
  • 27. Sequelae Rate: Retrograde Ejaculation [ Time Frame: 12 months ]
    register the number of retrograde ejaculation at 1, 3, 6, and 12 after surgery.
  • 28. Sequelae Rate: Dysuria [ Time Frame: 12 months ]
    register the number of dysuria at 1, 3, 6, and 12 after surgery.

Eligibility Criteria

  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

- Sign the informed consent voluntarily and will be willing to follow-up

- Prostate volume <80 g - Meet any conditions (1) Diagnose of LUTS due to refractory to drugs BPH. (2) presenting complications derived from BPH (bladder calculi, recurrent haematuria, recurrent urinary tract infections, acute urinary retention) - The use of antiplatelet agents or anticoagulant drugs is allowed. Exclusion Criteria: - Previous history of pelvic surgery - Previous history of pelvic radiotherapy - Previous history of neurogenic bladder dysfunction - Documented or suspected prostate carcinoma - Patients with severe cardiopulmonary disease or severe mental disorders - Poor compliance, and can not be followed up.

Contacts and Locations

Contacts

Locations

Spain, Madrid
Hospital Universitario de Fuenlabrada
Fuenlabrada

Sponsors and Collaborators

Hospital Universitario de Fuenlabrada

Investigators

Principal Investigator: Manuel Álvarez Ardura, M.D. Hospital Universitario de Fuenlabrada

Principal Investigator: Hugo Otaola Arca, M.D., Ph.D. Hospital Universitario de Fuenlabrada

Study Chair: Álvaro Páez Borda, M.D., Ph.D. Hospital Universitario de Fuenlabrada

More Information

  • Study Type: Interventional
  • Study Design: Allocation: Randomized;Intervention Model: Parallel Assignment;Masking: Single;Primary Purpose: Treatment
  • Condition: Transurethral Resection of Prostate
    Prostatic Hyperplasia
    Lower Urinary Tract Symptoms
  • Interventions : Device: Transurethral Resection of the Prostate (TURP)
  • Enrollment: 100

Participant flow

  • Recruitment Details
  • Pre-assignment Details

  • Arm/Group title PK-TURP M-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
    Period Title: Overall Study
  • Started 43 57
  • Completed 39 45
  • Not Completed 4 12
  • Reason Not Completed
  • Physician Decision 3 7
  • Lost to Follow-up 1 5
Baseline Characteristics
  • Arm/Group title TotalPK-TURPM-TURP
  • Arm/Group Description Total of all reporting groupsThe PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Baseline Participants 843945
  • Baseline Analysis Population Description [Not Specified]
Outcome Measures

1. PrimaryOutcome

  • Title Postvoid Residual Urine (PVRU) Volume
  • Description Postvoid residual urine volume (mL) was measured by abdominal ultrasound after urination at 1, 3, 6, and 12 months after surgery.
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: mL
  • 12 months 8.3
    14
  • 6 months 14.7
    15.3
  • 3 months 18.2
    22.8
  • 1 month 13
    14.2

2. PrimaryOutcome

  • Title Maximum Urinary Flow Rate (Qmax
  • Description Maximum urinary flow rate (mL/s) at 1, 3, 6, and 12 months after surgery.
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: mL/s
  • 1 months 18.9
    18.2
  • 12 months 19.2
    17.5
  • 6 months 18.7
    21.2
  • 3 months 16.8
    21

3. PrimaryOutcome

  • Title International Prostate Symptom Score (IPSS)
  • Description International Prostate Symptom Score (with 7 questions) at 1, 3, 6, and 12 months after surgery. Results: the sum of the 7 items will range between 0 to 35 points Interpretation: allows categorizing the lower urinary tract symptoms (LUTS) in 3 categories Mild LUTS: 0-7 points Moderate LUTS: 8-19 points Severe LUTS: 20-35 points
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: points
  • 12 months 7.4
    9.7
  • 6 months 9.4
    9.7
  • 3 months 11.3
    12.2
  • 1 month 12.7
    14.6

4. SecondaryOutcome

  • Title Prostate Volume (PV)
  • Description Prostate volume was measured by transrectal ultrasound at 12 months after surgery
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: mL
  • 22.5
    22.3

5. SecondaryOutcome

  • Title Sequelae Rate: Dysuria
  • Description register the number of dysuria at 1, 3, 6, and 12 after surgery.
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 12 months

  • 6 months

  • 3 months

  • 1 month
    5

6. SecondaryOutcome

  • Title Sequelae Rate: Retrograde Ejaculation
  • Description register the number of retrograde ejaculation at 1, 3, 6, and 12 after surgery.
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 12 months 18
    23
  • 6 months 17
    21
  • 3 months 18
    24
  • 1 month 13
    17

7. SecondaryOutcome

  • Title Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate
  • Description Register the number of patients with urge urinary incontinence without need for drug use at 1, 3, 6, and 12 after surgery.
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 1 month 4
    6
  • 6 months 4
    8
  • 3 months 3
    6
  • 12 months
    1

8. SecondaryOutcome

  • Title Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate
  • Description Register the number of patients with urge urinary incontinence with need for drug use at 1, 3, 6, and 12 after surgery.
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 12 months

  • 6 months 2
    3
  • 3 months 3
    3
  • 1 month 3
    9

9. SecondaryOutcome

  • Title Stress Urinary Incontinence Rate
  • Description Register the number of patients with stress urinary incontinence at 1, 3, 6, and 12 after surgery.
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 12 months
    3
  • 6 months 3
    7
  • 3 months 9
    12
  • 1 month 12
    18

10. SecondaryOutcome

  • Title Stenotic Complications Rate: Bladder Neck Contracture
  • Description Register the number of bladder neck contracture at 1, 3, 6, and 12 after surgery.
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 12 months
    1
  • 6 months
    2
  • 3 months
    1
  • 1 month

11. SecondaryOutcome

  • Title Stenotic Complications Rate: Urethral Stricture
  • Description Register the number of urethral stricture at 1, 3, 6, and 12 after surgery.
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 12 months 2
    1
  • 6 months 2
    2
  • 3 months 1
    2
  • 1 month

12. SecondaryOutcome

  • Title Stenotic Complications Rate: Meatal Stenosis
  • Description Register the number of meatal stenosis at 1, 3, 6, and 12 after surgery.
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 3 months 2
    5
  • 1 month 2
    2
  • 12 months 2
    4
  • 6 months
    2

13. SecondaryOutcome

  • Title Urinary Tract Infections Rate
  • Description Register the number of urinary tract infections at 1, 3, 6, and 12 months after surgery.
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 12 months

  • 6 months

  • 3 months

  • 1 month 1
    5

14. SecondaryOutcome

  • Title Bleeding Complications Rate
  • Description Register the number of events of haematuria and acute urinary retention by clots
  • Time Frame 1 month
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 7
    8

15. SecondaryOutcome

  • Title Clavien Dindo System
  • Description It is a system for evaluating surgical complications at 12 months after surgery. Clavien I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Acceptable therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, diuretics and electrolytes, and physiotherapy. Clavien II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included Clavien III - Requiring surgical, endoscopic or radiological intervention Clavien IV - Life-threatening complication (including central nervous system complications) requiring intensive care unit management Clavien V - Death of a patient
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • Clavien V

  • Clavien IV

  • Clavien III 1
    2
  • Clavien II 2
    2
  • Clavien I 2
    2

16. SecondaryOutcome

  • Title Post-TURP Syndrome Rate
  • Description Post-transurethral resection of the prostate syndrome rate was recorded.
  • Time Frame Up to 24 hours
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants

  • 1

17. SecondaryOutcome

  • Title Late Reoperation Rate
  • Description The ratio of patient who need reoperation because residual adenoma or complications
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 1
    2

18. SecondaryOutcome

  • Title Early Reoperation Rate
  • Description The ratio of patient who need reoperation because bleeding complications
  • Time Frame 1 month
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 1
    2

19. SecondaryOutcome

  • Title Speed Resection
  • Description Speed resection (g/min)
  • Time Frame Up to 24 hours
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: g/min
  • 0.9
    0.9

20. SecondaryOutcome

  • Title Resected Tissue Percentage
  • Description Compared with the baseline, to demonstrate the % of tissue loss during operation
  • Time Frame Up to 24 hours
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: % of resected tissue
  • 28.8
    33.5

21. SecondaryOutcome

  • Title Resected Tissue Weigh
  • Description Resected tissue weigh (grams)
  • Time Frame Up to 24 hours
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: grams
  • 12.4
    12.7

22. SecondaryOutcome

  • Title Hospital Stay
  • Description Hospital stay (days)
  • Time Frame 1 month
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: days
  • 1.1
    1.1

23. SecondaryOutcome

  • Title Catheter Duration
  • Description Catheter duration (days)
  • Time Frame 1 month
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: days
  • 3.5
    3.6

24. SecondaryOutcome

  • Title Transfusion Rate
  • Description Number of participants requiring blood transfusion during, expressed in %
  • Time Frame 1 month
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants


25. SecondaryOutcome

  • Title Change in Haemoglobin in 24 Hours Post-operation
  • Description Compared with the baseline, to demonstrate the blood loss during operation
  • Time Frame 24 hours after surgery
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: mg/dL
  • 1
    0.9

26. SecondaryOutcome

  • Title Change in Plasmatic Sodium in 24 Hours Post-operation
  • Description Compared with the baseline, to demonstrate the sodium loss during operation
  • Time Frame 24 hours after surgery
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: mEq/L
  • 2.2
    3.3

27. SecondaryOutcome

  • Title Irrigation Volume
  • Description Irrigation volume (L)
  • Time Frame Up to 24 hours
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: L
  • 20.2
    16

28. SecondaryOutcome

  • Title Operative Time
  • Description Operative time (min)
  • Time Frame Up to 24 hours
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: minutes
  • 47.7
    39.7

29. SecondaryOutcome

  • Title International Index of Erectile Function (IIEF-5)
  • Description International Index of Erectile Function (with 5 questions) at 1, 3, 6, and 12 months after surgery. Results: the sum of the 5 items will range between 1 to 25 points Interpretation: allows categorizing the erectile function of patients Without erectile dysfunction: 22-25 points Mild erectile dysfunction: 17-21 points Mild to moderate erectile dysfunction: 12-16 points Moderate erectile dysfunction: 8-11 points Severe erectile dysfunction: 1-7 points
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: points
  • 12 months 11
    9.7
  • 6 months 12.4
    10.7
  • 3 months 10.7
    9.9
  • 1 month 9.5
    8.5

30. SecondaryOutcome

  • Title Number of Participants Reporting Sexual Activity in the Last Month
  • Description Measure Description: All patients were asked, Did you have sexual activity in the last month? Possible answers were yes or no. Possible answers: yes or no. Measurement moment: at 1, 3, 6 and 12 months after surgery.
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 12 months 30
    29
  • 6 months 29
    30
  • 3 months 28
    33
  • 1 month 22
    23

31. SecondaryOutcome

  • Title Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire
  • Description We use the bother score item of the IPSS questionnaire (question 8) at 1, 3, 6, and 12 months after surgery to assess the quality of life (QoL) due to lower urinary tract symptoms (LUTS) Results: will range between 0 to 6 points Interpretation: allows categorizing the QoL in 3 categories Good QoL: 0-2 points Intermediate QoL: 3 points Poor QoL: 4-6points
  • Time Frame 12 months
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
  • Overall Number of Participants Analyzed 3945
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: points
  • 12 months 1.5
    2.4
  • 6 months 1.6
    2.3
  • 3 months 2.6
    2.9
  • 1 month 2.9
    3.7
Adverse Events
  • Time Frame 1 year
  • Adverse Event Reporting Description Clavien-Dindo classification
  •  
  • Arm/Group Title PK-TURPM-TURP
  • Arm/Group Description The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURPThe M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP

All-Cause Mortality

  • M-TURP PK-TURP
  • Affected at Risk (%) Affected at Risk (%)
  • Total 0/45 (0.00%) 0/39 (0.00%)
  • Total
  • Total, all-cause mortality 0 /45 (0.00%) 0 /39 (0.00%)

Serious Adverse Events

  • M-TURP PK-TURP
  • Affected at Risk (%) Affected at Risk (%)
  • Total 2/45 (4.44%) 1/39 (2.56%)
  • Renal and urinary disorders
  • Need for reintervention 2 /45 (4.44%) 1 /39 (2.56%)
  • Total
  • Total, serious adverse events 2 /45 (4.44%) 1 /39 (2.56%)

Show Other (Not Including Serious) Adverse Events

  • M-TURP PK-TURP
  • Affected / at Risk (%) Events Affected / at Risk (%) Events
  • Total 4/45 (8.89%) 4/39 (10.26%)
  • Renal and urinary disorders
  • Stenotic events without the need for surgery 4 /45 (8.89%) 4 4 /39 (10.26%) 4
  • Total
  • Total, other adverse events 4 /45 (8.89%) 0 4 /39 (10.26%) 0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

  • Name/Title:Dr. Hugo Otaola Arca
  • Organization:Hospital Universitario Fuenlabrada
  • Phone:+56 9 4108 9452
  • EMail:hugotaolarca@hotmail.com
  • ClinicalTrials.gov Identifier: NCT03936244 History of Changes
  • Other Study ID Numbers: HUF
  • First Submitted: April 24, 2019
  • First Posted: May 3, 2019
  • Results First Submitted: July 2, 2020
  • Results First Posted: October 19, 2020
  • Last Update Posted: November 12, 2020